Bortezomib may be safely combined with Y-90-ibritumomab tiuxetan in patients with relapsed/refractory follicular non-Hodgkin lymphoma: a phase I trial of combined induction therapy and bortezomib consolidation

Leuk Lymphoma. 2013 Mar;54(3):497-502. doi: 10.3109/10428194.2012.722215. Epub 2012 Sep 11.

Abstract

Preclinical studies suggest that bortezomib, through inhibition of nuclear factor-κB (NF-κB) activation, may enhance the effects of radioimmunotherapy. This phase I trial was designed to determine the maximum tolerated dose (MTD) of weekly bortezomib induction combined with Y-90-ibritumomab tiuxetan followed at the time of count recovery by weekly bortezomib consolidation in patients with relapsed/refractory follicular or transformed non-Hodgkin lymphoma. Grade 3 or 4 toxicities were observed in eight of nine treated patients, and all but one of these toxicities were hematologic. One patient had grade 3 cardiotoxicity. A dose limiting toxicity (DLT) of grade 4 thrombocytopenia was observed in two of three patients treated with bortezomib at 1.6 mg/m(2), resulting in a MTD of 1.3 mg/m(2). The overall response rate was 89% (two complete response [CR], six partial response [PR], one stable disease [SD]), with a median progression-free survival of 6.5 months (range: 3-22.5+ months). A phase II trial at the MTD is under way to better define the toxicity and effectiveness of this regimen.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Antineoplastic Agents / therapeutic use
  • Boronic Acids / therapeutic use*
  • Bortezomib
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Resistance, Neoplasm
  • Female
  • Follow-Up Studies
  • Humans
  • Induction Chemotherapy / adverse effects
  • Induction Chemotherapy / methods
  • Lymphoma, Non-Hodgkin / pathology
  • Lymphoma, Non-Hodgkin / therapy*
  • Male
  • Middle Aged
  • Neutropenia / etiology
  • Pyrazines / therapeutic use*
  • Radioimmunotherapy / adverse effects
  • Radioimmunotherapy / methods
  • Recurrence
  • Treatment Outcome
  • Yttrium Radioisotopes

Substances

  • Antibodies, Monoclonal
  • Antineoplastic Agents
  • Boronic Acids
  • Pyrazines
  • Yttrium Radioisotopes
  • ibritumomab tiuxetan
  • Bortezomib